WartsNCT06309420
Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts
A study testing Cryogenic treatment of warts (Pixie CO2) and Cryogenic treatment of warts (Wortie®) in people with Warts, run by Oystershell NV at 1 site in Poland.
Trial summary
The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Warts
- What is being tested?
- Cryogenic treatment of warts (Pixie CO2) and Cryogenic treatment of warts (Wortie®)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePoland
- Study dates
- 7 Nov 2019to 10 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subject.
- Sex: male or female.
- Age: more than 4 years old.
- Subject presenting at least 1 new common wart on hand or a plantar wart (wart present since less than 6 months) of a size less than 0.8cm.
- Subject, including minors aged more than 16 years, having given freely and expressly his/her informed consent.
- Minor whose legal guardians have given their free and express informed consent.
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- Subject who is able to comply with the study requirements, as defined in the present rotocol, at the Investigator's appreciation.
- Subject or child's legal guardians being affiliated to a health social security system.
- Female subject of childbearing potential should use a medically accepted contraceptive regimen (at the Investigator's discretion) since at least 12 weeks before the beginning of the study, during all the study.
Who cannot join
- Pregnant, parturient, or nursing woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision.
- Subject in a social or sanitary establishment.
- Major subject who is under guardianship or who is not able to express his consent.
- Subject suspected to be non-compliant according to the Investigator's judgment.
- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
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- Subject with a cutaneous disease other than common and plantar warts, on the studied zone.
- Subject with a known allergy to one of the component of the products or to the comparator.
- Subject who has diabetes.
- Subject having problems with blood circulation, or having a blood clotting condition.
- Subject with immune deficiency or autoimmune disease.
- Subject presenting more than 10 warts on the body.
- Subject presenting bleeding warts.
- Subject presenting birthmarks, moles, warts with hairs growing from them, or any other spots on the treated and surrounding area.
- Subject having a sensitive skin, inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy on the treated zone.
- Subject presenting genital warts, flat warts, filiform warts, periungual warts or warts larger than 0.8cm.
- Subject presenting 2 or more warts adjacent to each other.
- Subject undergoing a topical treatment on the test area or a systemic treatment:
- anti-inflammatory medication during the previous 2 weeks and during the study,
- immunosuppressors and/or corticoids during the 4 previous weeks and during the study,
- retinoids during the 6 previous months and during the study,
- any medication stabilized for less than one month.
- Subject who received a treatment of any type on the selected wart during the previous 6 months.
- Intensive exposure to sunlight or UV-rays on the studied zone within the previous month and/or foreseen during the study.
- Subject planning to change her/his life habits during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device in Treatment of Common and Plantar Warts Versus a Comparator Product.
The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts.
Read the detailed description
The use of cryotherapy has been long known to be effective against warts. The indications for Pixie CO2 are in line with the indications presented in the collected literature data, as well as with the indications of similar devices.
The benefits of the use of cryotherapy for warts is clearly evidenced. The treatment period is short (up to 3 treatments with a 14 day interval, compared to daily application of keratinolytics or fluorouracil, over a period of weeks). The cryotherapy application through a conic applicator is much more precise than with most chemical substances. Chemical substance application is leading to more side effects of the surrounding skin (typical for chemical treatment are pain, blistering, ulceration and contact dermatitis).
The Instructions for Use were developed in line with these data and are therefore covering all hazards known up to the date of this report.
Based on these data the product received its CE-mark approval.
- Conditions
- Warts
- Being tested
- Cryogenic treatment of warts (Pixie CO2), Cryogenic treatment of warts (Wortie®)
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryogenic treatment of warts (Pixie CO2)Device
Also called X92001686
Treatment of common and plantar warts by cryotherapy treatment.
Cryogenic treatment of warts (Wortie®)Device
Treatment of common and plantar warts by cryotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pixie CO2 | Experimental | Cryogenic treatment of warts (Carbonic ice tablet) Maximum 3 application by the technician in charge of the study Apply 15 seconds for a wart on hand or arm and 40 seconds for a wart on feet or toe Receives: Device: Cryogenic treatment of warts (Pixie CO2) |
| Wortie® | Active comparator | Cryogenic treatment of wart (dimethylether-based product) Maximum 3 application by the technician in charge of the study. Apply 20 seconds for a wart on hand or arm and 40 seconds for a wart on feet or toe Receives: Device: Cryogenic treatment of warts (Wortie®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with clinical wart remission
Comparison of the percentage of subjects with clinical wart remission after 1, 2 and 3 treatments with the tested product group versus comparator group, as observed during clinical evaluation of the treated wart by a dermatologist.
Measured: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
Secondary outcomes (8)
Number of treatments
Comparison of the number of treatments needed for clinical remission of warts with both products
Measured: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
Efficacy of the freezing process (Surface Area)
Surface area measurements of frostbite area to evaluate the efficacy of the freezing process
Measured: Measurement treatment 1 (Day 0), Measurement treatment 2 (Day 15), Measurement treatment 3 (Day 30)
Diameter of the wart
Macrophotography of the wart
Measured: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Roughness of the wart
Evaluation of roughness of the wart by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe
Measured: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Thickness of the wart (For common warts only)
Evaluation of thickness of the wart by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe
Measured: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Presence of small dark spot (For plantar warts only)
Evaluation of presence of a small dark spot by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe
Measured: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Healing process of the wart
Evaluation of healing process of the wart by blinded dermatologist.
This is done by assessing:
- Discontinuation of skin lines (5 categories: 0=none, 1=light, 2=moderate, 3=severe, and 4=very severe)
- Affection of skin color (5 categories: 0=none, 1=light, 2=moderate, 3=severe, and 4=very severe)
- Presence/absence of a scab.
Measured: After 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Local & general tolerance
Evaluate the safety of the products by assessing local \& general tolerance. Local tolerance will be assessed by using the following scale (0= Bad tolerance, 1= Moderade tolerance, 2= Good tolerance, 3=Very good tolerance.) Abnormal clinical signs and subjective signs reported by the subjects will be reported in the CRF.
The general tolerance is a collection of adverse events by the investigator.
Measured: When wart is considered cured at Day 15, Day 30 or Day 45 or at the end of study on Day 45.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start7 Nov 2019
- Primary completion10 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-blinded, Randomized,Tested product versus comparator (benchmark product), In parallel groups, With multiple applications, Single centre.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ewa KARAMON, Principal investigator, ewaczek20@wp.pl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309420
- Sponsor's protocol ID
- 19E0566
- Status last verified
- Mar 2024
- First submitted
- 16 Dec 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device in Treatment of Common and Plantar Warts Versus a Comparator Product.
- ClinicalTrials.gov ID
- NCT06309420
- Acronym / sponsor ID
- 19E0566
- Conditions
- Warts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts.
Detailed description
The use of cryotherapy has been long known to be effective against warts. The indications for Pixie CO2 are in line with the indications presented in the collected literature data, as well as with the indications of similar devices.
The benefits of the use of cryotherapy for warts is clearly evidenced. The treatment period is short (up to 3 treatments with a 14 day interval, compared to daily application of keratinolytics or fluorouracil, over a period of weeks). The cryotherapy application through a conic applicator is much more precise than with most chemical substances. Chemical substance application is leading to more side effects of the surrounding skin (typical for chemical treatment are pain, blistering, ulceration and contact dermatitis).
The Instructions for Use were developed in line with these data and are therefore covering all hazards known up to the date of this report.
Based on these data the product received its CE-mark approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Investigator-blinded, Randomized,Tested product versus comparator (benchmark product), In parallel groups, With multiple applications, Single centre.
| Arm | Type | Receives |
|---|---|---|
| Pixie CO2 | Experimental | Device: Cryogenic treatment of warts (Pixie CO2)Cryogenic treatment of warts (Carbonic ice tablet) Maximum 3 application by the technician in charge of the study Apply 15 seconds for a wart on hand or arm and 40 seconds for a wart on feet or toe |
| Wortie® | Active comparator | Device: Cryogenic treatment of warts (Wortie®)Cryogenic treatment of wart (dimethylether-based product) Maximum 3 application by the technician in charge of the study. Apply 20 seconds for a wart on hand or arm and 40 seconds for a wart on feet or toe |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy subject.
- Sex: male or female.
- Age: more than 4 years old.
- Subject presenting at least 1 new common wart on hand or a plantar wart (wart present since less than 6 months) of a size less than 0.8cm.
- Subject, including minors aged more than 16 years, having given freely and expressly his/her informed consent.
Key exclusion criteria (25 listed)
- Pregnant, parturient, or nursing woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision.
- Subject in a social or sanitary establishment.
- Major subject who is under guardianship or who is not able to express his consent.
- Subject suspected to be non-compliant according to the Investigator's judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryogenic treatment of warts (Pixie CO2)Also: X92001686Treatment of common and plantar warts by cryotherapy treatment. | Device | Pixie CO2 |
| Cryogenic treatment of warts (Wortie®)Treatment of common and plantar warts by cryotherapy treatment. | Device | Wortie® |
Primary outcome
Percentage of subjects with clinical wart remission
Time frame: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
Comparison of the percentage of subjects with clinical wart remission after 1, 2 and 3 treatments with the tested product group versus comparator group, as observed during clinical evaluation of the treated wart by a dermatologist.
8 secondary outcomes
Number of treatments
Time frame: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
Efficacy of the freezing process (Surface Area)
Time frame: Measurement treatment 1 (Day 0), Measurement treatment 2 (Day 15), Measurement treatment 3 (Day 30)
Diameter of the wart
Time frame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Roughness of the wart
Time frame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Thickness of the wart (For common warts only)
Time frame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Presence of small dark spot (For plantar warts only)
Time frame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Healing process of the wart
Time frame: After 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Local & general tolerance
Time frame: When wart is considered cured at Day 15, Day 30 or Day 45 or at the end of study on Day 45.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa KARAMON principal investigator
ewaczek20@wp.pl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryogenic treatment of warts (Pixie CO2) and Cryogenic treatment of warts (Wortie®) in people with Warts, run by Oystershell NV at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with clinical wart remission (time frame: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.